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ENROLLING BY INVITATION
NCT07228403
PHASE3

Efficacy and Safety Evaluation of Glepaglutide in Treatment of Short Bowel Syndrome

Sponsor: Zealand Pharma

View on ClinicalTrials.gov

Summary

The purpose of this study is to understand the safety and efficacy of twice weekly glepaglutide 10 mg in adult patients with short bowel syndrome (SBS), who were previously enrolled in the EASE SBS 2 or EASE SBS 3 trials. Participants currently on these trials will be able to continue their glepaglutide treatment by enrolling in this EASE SBS 6 extension trial. The trial includes a 24-month treatment period, followed by a 4-week safety follow-up period. Participants will attend trial visits, where they may undergo heart tests (electrocardiogram (ECG)), vital sign checks, colonoscopies, blood and urine tests, and physical exams.

Official title: A 104-week, Multicenter, Open-label, Single-arm, Phase 3 Extension Trial Investigating the Long-term Safety and Efficacy of Glepaglutide in Adult Patients With Short Bowel Syndrome (SBS) Rolling Over From the EASE SBS 2 or 3 Trials

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

35

Start Date

2025-12-11

Completion Date

2028-12-31

Last Updated

2026-02-02

Healthy Volunteers

No

Interventions

DRUG

Glepaglutide 10 mg

Administered twice weekly by subcutaneous injection for a maximum of 24 months

Locations (16)

Mayo Clinic - PPDS

Rochester, Minnesota, United States

Lied Transplant Center at Nebraska Medical Center

Omaha, Nebraska, United States

Cleveland Clinic-9500 Euclid Ave

Cleveland, Ohio, United States

Vanderbilt University Medical Center-Tennesse-1211 21st Ave S

Nashville, Tennessee, United States

UZ Leuven - PPDS

Leuven, Belgium

LHSC - University Hospital

London, Ontario, Canada

AP-HP - Hôpital Beaujon

Clichy, Hauts-de-Seine, France

Universitätsklinikum Frankfurt

Frankfurt am Main, Hesse, Germany

Universitätsmedizin Rostock

Rostock, Mecklenburg-Vorpommern, Germany

Universitätsklinikum Bonn

Bonn, North Rhine-Westphalia, Germany

Charité - Universitätsmedizin Berlin

Berlin, State of Berlin, Germany

Asklepios Klinik St. Georg

Hamburg, Germany

Szpital Skawina sp. z o.o. im. Stanley Dudricka

Skawina, Lesser Poland Voivodeship, Poland

Samodzielny Publiczny Szpitala Kliniczny im. Prof. Witolda Orlowskiego CMKP

Warsaw, Masovian Voivodeship, Poland

Wojewódzki Szpital Specjalistycznyo im. M. Pirogowa w Lodzi

Lodz, Poland

St Mark's Hospital (Central Middlesex Hospital)

Ealing, United Kingdom